An educational tool for signal identification in quality assurance within the medicinal products regulatory sciences

Abstract

Introduction: The identification and interpretation of signals play a crucial role in the accessibility of safe, high quality, and effective pharmaceuticals. Signals are essential tools within quality assurance frameworks, particularly in the evaluation of intricate factors such as competence and compliance. This study proposes a methodological framework aimed at constructing an educational tool to strengthen signal management within the realm of quality assurance in medicinal products regulatory sciences. Aims: 1. Detect signals emanating from sources within the regulatory framework 2. Classify signals based on quantitative and qualitative criteria 3. Establish a proactive procedure for signal management 4. Formulate strategic action plans for signal optimisation 5. Introduce novel terminology.